The Effect of Eye Masks and Earplugs on Sleep Quality and Life Findings In Intensive Care Unit Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Vital signs follow-up form
研究概览
简要总结
This study was planned as a randomized controlled and experimental study to evaluate the effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.
详细描述
The research will be conducted with 60 patients hospitalized in the intensive care units of a state hospital. Research data will be collected with a questionnaire, vital signs follow-up form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be divided into intervention and control groups. Eye mask and ear plugs will be applied to the intervention group for 3 days, and the control group will receive routine care. The study will be terminated after 3 days of follow-up for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Only participants were blinded in the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and over,
- •Able to answer all questions and communicate,
- •Those who agreed to participate in the research
- •Being in the category of insomnia, moderate insomnia, or severe insomnia according to the insomnia severity index,
- •Not sedating
- •Not connected to a ventilator
- •No hearing problem
- •Glasgow Coma Score of 15
排除标准
- •Connecting to the ventilator during operation
- •Sedation during the study
- •Wanting to leave the research during the study
- •Being in the intervention group and removing the eye patch or earplug during sleep
- •GCS falling below 15
结局指标
主要结局
Vital signs follow-up form
时间窗: up to 3 days
It will be used to measure patients' fever, pulse, respiration, blood pressure and sPO2 values. It will be applied to patients at 22, 02, 06 hours. Also, the daily average hour will be calculated at the end of each day.
Personal questionnaire
时间窗: Only one times. At the first meeting (up to one day).
It is a form consisting of 22 questions in order to investigate the sociodemographic characteristics and health status of the patients.
Insomnia Severity Index
时间窗: up to 3 days
It will be used to measure the severity of insomnia in patients. It consists of 7 questions and each question can receive points between 0 and 4. A maximum score of 28 and a minimum score of 0 are obtained on the scale, and as the score increases, the severity of insomnia increases.
Richards-Campbell Sleep Scale
时间窗: up to 3 days
The scale consists of 6 questions and the question is between 0 and 100 points. The higher the score, the higher the sleep quality.
次要结局
未报告次要终点
研究者
onur çetinkaya, PhD
Lecturer
Osmaniye Korkut Ata University